Monitoring Devices in Prediction of Fluid Responsiveness in Severe Sepsis and Septic Shock

Santa Barbara Cottage Hospital38 enrolled

Overview

Comparison of noninvasive cardiac output monitor (NICOM, Cheetah Medical) with Edwards FloTrac minimally-invasive cardiac output monitor in predicting fluid responsiveness in sepsis and septic shock.

Study will evaluate ability of passive leg raise test to predict fluid responsiveness in patients in septic shock, on vasopressors, using both the NICOM and FloTrac devices. An increase in CI, SVI, or Pulse Pressure of \>10% in response to the passive leg raise will be considered a positive passive leg raise test, and the same indicators will be considered a significant response to a fluid challenge with either crystalloids or colloids.Each device will be evaluated independently, but simultaneously.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Severe Sepsis Septic Shock

Interventions

NICOM/FloTracDEVICE

Use of noninvasive cardiac output and minimally invasive cardiac output monitors

Crystalloid Fluid ChallengeOTHER

500-1000ml Normal Saline or Plasmalyte intravenous fluid bolus will be given at baseline, and following a positive passive leg raise response as defined by a 10% or greater increase in any of: stroke volume index, cardiac index, or pulse pressure, as measured by the NICOM or FloTrac Monitors.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All adult patients with severe sepsis or septic shock, who have arterial catheter placed with FloTrac monitor, with or without a central venous catheter. Exclusion Criteria: * Declination of consent * Known allergy to adhesive * Pregnancy * Contraindication to raising legs or head to 45 degrees for 3 minute intervals

Locations (1)

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Outcomes

Primary Outcomes

Number of participants who have agreement or disagreement between passive leg raise response and subsequent intravenous fluid challenge

Positive passive leg raise response is defined as a 10% or greater increase in any of: stroke volume index, cardiac index, or pulse pressure following passive leg raise of 45 degrees for 3 minutes. Positive response to fluid challenge is defined as a 10% or greater increase in any of the same parameters following a 500ml or 1000 ml fluid challenge given over 10-15 minutes, using the same instrument, (NICOM or FloTrac). A negative response would be \< 10% increase in these parameters using the same instrument

Time frame: 15 minutes

Secondary Outcomes

Decrease in vasopressor dose, in response to fluid therapy guided by passive leg raise response using NICOM or Flotrac devices

Time frame: 48 hours

Data from ClinicalTrials.gov

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